PCOSPhase 3COMET-PCOSNCT03229057

Comparing the Effects of Oral Contraceptive Pills Versus Metformin

A Phase 3 study testing OCP + Metformin in people with PCOS, run by Anuja Dokras at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To determine the effect of Oral Contraceptive Pills (OCP) verses Metformin verses OCP and Metformin on the prevalence of Metabolic Syndrome (MetS) and its components in overweight/obese women with Polycystic Ovary Syndrome (PCOS). Read more about this study

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: PCOS
What is being tested?: OCP + Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 2 sitesUnited States
Study dates: 15 Jan 2018to 15 Jul 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

Women ≥ 18 to ≤ 40 years of age (at the time of screening), with hyperandrogenic PCOS.
Subjects will be diagnosed with PCOS defined by the most recent Rotterdam criteria based on:
androgen excess (defined as an elevated serum T level or hirsutism, based on a Ferriman Gallwey score > 8 (note: > 2 for women of Asian descent)
AND either:
history of chronic anovulation (8 or fewer periods per year)
AND/OR

Show all 10Show fewer

polycystic ovaries.
BMI ≥ 25 kg/m² to ≤ 48 kg/m² obtained at screening visit.
In good general health.
Willing to avoid pregnancy for the duration of the study.

Who cannot join

Current pregnancy or desire of pregnancy during course of study
Currently breastfeeding
Known 21 hydroxylase deficiency
Untreated thyroid disease (TSH <0.45 mlU/mL and > 4.5 mlU/mL)
Untreated hyperprolactinemia (2 Levels>30 ng/ml at least one week apart)
Type 1 or type 2 Diabetes Mellitus (elevated fasting serum glucose >126mg/dL on two occasions, poorly controlled diabetes (HgbA1C>6.5%), currently receiving anti-diabetic agents, or currently receiving metformin for treatment of diabetes

Show all 22Show fewer

Liver disease (AST/ALT>2 times normal or a total bilirubin >2.5 mg/dL)
Renal disease (BUN>30 mg/dL or serum creatinine >1.4 mg/dL)
Anemia (hemoglobin <10 mg/dL)
History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident
Current history of alcohol abuse (>14drinks/week)
Poorly controlled hypertension defined as average systolic blood pressure >= 150 mm Hg or average diastolic >=100 mm Hg obtained on three measurements obtained 5 minutes apart. If treated, average systolic blood pressure >=140 mm Hg or average diastolic >=90 mm Hg
Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma
TG>200mg/dl
Use of lipid lowering or weight loss agents (subjects may wash out from weight loss agents)
Current use of oral contraceptives, depo progestin, or hormonal implants
Participation in any study of an investigational drug or device or biological agent within 30 days
Suspected adrenal or ovarian tumor secreting androgens
Suspected Cushing's syndrome
Bariatric surgery procedure in the recent past (<12 months)
Absolute contraindications to the use of hormonal contraceptives or metformin,
23. Subjects who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Penn State/ Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Comparing the Effects of Oral Contraceptive Pills Versus Metformin in the Medical Management of Overweight/Obese Women With Polycystic Ovary Syndrome

The combination of OCP and metformin (OCP, through lowering androgens, and metformin, through improvement in insulin sensitivity) will affect the prevalence of MetS, thereby altering the risk profile for the development of diabetes and possible cardiovascular disease (CVD) in young women with PCOS.

Read the detailed description

The intervention will consist of randomizing subjects to one of three arms. Subjects will either be assigned to OCP + Placebo, Metformin + Placebo or OCP + Metformin. Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. In regards to OCP, previous randomized clinical trials (RCTs) have shown that 20mcg ethinyl estradiol/norethindrone 1.0 mg was well tolerated. The study will utilize a 20mcg OCP but a less androgenic third generation progestin (desogestrel 0.15mg) with potentially lesser impact on lipids and insulin sensitivity. The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP or metformin only in order to maintain study blinding. Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects

Conditions: PCOS
Being tested: OCP + Metformin, OCP + Placebo, Metformin + Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OCP + MetforminDrug
This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
OCP + PlaceboDrug
This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
Metformin + PlaceboDrug
This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.

Study groups in NCT03229057
Study group	Role	What they receive
OCP + Placebo	Active comparator	The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding. Receives: Drug: OCP + Placebo
Metformin + Placebo	Active comparator	Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding. Receives: Drug: Metformin + Placebo
OCP + Metformin	Experimental	The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Receives: Drug: OCP + Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months.
Our primary goal is to determine the effect of 6 months' treatment with OCP vs. metformin vs. OCP + metformin on prevalence of MetS and its components in overweight / obese women. Implicit in the primary aim is clearly defining MetS, by NCEP ATPIII criteria as the presence of at least 3 of the following 5 criteria: TG≥150mg/dl, HDL-C<50mg/dl, BP≥130/≥85mmHg, WC>88cm and fasting glucose≥100mg/dl; and the goal of tracking safety of our interventions at all Phases of the study (through safety lab evaluations, vital signs and diaries)
Measured: Baseline and 6 months

Secondary outcomes (9)

Changes in Serum Apoliprotein B From Baseline to 6 Months
This will be measured by NMR spectroscopy
Measured: Baseline and 6 months
Changes in Serum Adipokines in the 3 Arms
Serum adipokines to be measured are adiponectin and leptin. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity.
Measured: Baseline and 6 months
Changes in Total Body Fat Distribution in the 3 Arms From Baseline to 6 Months
Body fat distribution will be measured by DXA. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity
Measured: Baseline and 6 months
Changes in Total Triglyceride-Rich Lipoprotein (TRLP) From Baseline to 6 Months
This will be measured by NMR spectroscopy
Measured: Baseline and 6 months
Changes in Serum Marker of Inflammation: Free Fatty Acids.
Measured by change in Free Fatty Acids
Measured: Baseline and 6 months
Changes in Quality of Life Parameters for Body Hair in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months
QOL will be measured by the Polycystic Ovary Syndrome Questionnaire (PCOSQ) Body Hair domain which has 5 items rated on a 7 point likert scale with a lower score representing a decreased quality of life. The total range is 7 to 35.
Measured: Baseline and 6 months
Changes in Visceral Body Fat Distribution in the 3 Arms
Body fat distribution will be measured by DXA. These changes will be correlated with changes in serum and androgens and markers of insulin sensitivity
Measured: Baseline and 6 months
Changes in Quality of Life Parameters for Weight in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months
QOL will be measured by the Polycystic Ovary Syndrome Questionnaire (PCOSQ) Weight domain which has 5 items rated on a 7 point likert scale with a lower score representing a decreased quality of life. The total range is 7 to 35.
Measured: Baseline and 6 months
Change in HDL-C Function
This will be assessed by measuring reverse cholesterol efflux capacity using validated ex vivo system.
Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201815 Jul 2024

First posted25 Jul 2017
Study start15 Jan 2018
Primary completion23 Jan 2024
Study completion15 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PCOSStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits. No longer term follow-up is planned.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03229057
Sponsor's protocol ID: 827819
Other IDs: 5R01HD091350-05
Acronym: COMET-PCOS
Status last verified: Sep 2025
First submitted: 13 Jul 2017
Last updated: 5 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Dokras A, Coutifaris C, Remaley AT, Mehta NN, Playford MP, Kunselman AR, Stetter CC, Dodson WC, Legro RS. Impact of combined hormonal contraceptives and metformin on metabolic syndrome in women with hyperandrogenic polycystic ovary syndrome and obesity: The COMET-PCOS randomized clinical trial. PLoS Med. 2025 Dec 8;22(12):e1004662. doi: 10.1371/journal.pmed.1004662. eCollection 2025 Dec.
PubMed 41359669

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing the Effects of Oral Contraceptive Pills Versus Metformin in the Medical Management of Overweight/Obese Women With Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT03229057
Acronym / sponsor ID: COMET-PCOS / 827819
Conditions: PCOS
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Anuja DokrasUniversity, hospital or other
Collaborators: Milton S. Hershey Medical Center, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 15 Jan 2018 (actual)
Primary completion: 23 Jan 2024 (actual)
Study completion: 15 Jul 2024 (actual)
First posted: 25 Jul 2017 (actual)
Results: Posted 10 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3
Model description: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits. No longer term follow-up is planned.

Arm	Type	Receives
OCP + Placebo	Active comparator	Drug: OCP + PlaceboThe OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding.
Metformin + Placebo	Active comparator	Drug: Metformin + PlaceboMetformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding.
OCP + Metformin	Experimental	Drug: OCP + MetforminThe OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Women ≥ 18 to ≤ 40 years of age (at the time of screening), with hyperandrogenic PCOS.
Subjects will be diagnosed with PCOS defined by the most recent Rotterdam criteria based on:
AND/OR
BMI ≥ 25 kg/m² to ≤ 48 kg/m² obtained at screening visit.
In good general health.

Key exclusion criteria (22 listed)

Current pregnancy or desire of pregnancy during course of study
Currently breastfeeding
Known 21 hydroxylase deficiency
Untreated thyroid disease (TSH <0.45 mlU/mL and > 4.5 mlU/mL)
Untreated hyperprolactinemia (2 Levels>30 ng/ml at least one week apart)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OCP + MetforminThis will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.	Drug	OCP + Metformin
OCP + PlaceboThis will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.	Drug	OCP + Placebo
Metformin + PlaceboThis will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.	Drug	Metformin + Placebo

Primary outcome

Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months.
Time frame: Baseline and 6 months
Our primary goal is to determine the effect of 6 months' treatment with OCP vs. metformin vs. OCP + metformin on prevalence of MetS and its components in overweight / obese women. Implicit in the primary aim is clearly defining MetS, by NCEP ATPIII criteria as the presence of at least 3 of the following 5 criteria: TG≥150mg/dl, HDL-C<50mg/dl, BP≥130/≥85mmHg, WC>88cm and fasting glucose≥100mg/dl; and the goal of tracking safety of our interventions at all Phases of the study (through safety lab evaluations, vital signs and diaries)

9 secondary outcomes

Changes in Serum Apoliprotein B From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Serum Adipokines in the 3 Arms
Time frame: Baseline and 6 months
Changes in Total Body Fat Distribution in the 3 Arms From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Total Triglyceride-Rich Lipoprotein (TRLP) From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Serum Marker of Inflammation: Free Fatty Acids.
Time frame: Baseline and 6 months
Changes in Quality of Life Parameters for Body Hair in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months
Time frame: Baseline and 6 months
Changes in Visceral Body Fat Distribution in the 3 Arms
Time frame: Baseline and 6 months
Changes in Quality of Life Parameters for Weight in All 3 Arms as Assessed by PCOSQ From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in HDL-C Function
Time frame: Baseline and 6 months

Results and safety

Results posted to the registry on 10 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OCP + Placebo	79	52
Metformin + Placebo	81	60
OCP + Metformin	80	57

Primary outcome: Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months.

Time frame: Baseline and 6 months. Count of participants. Unit: Participants

Measure	OCP + Placebo n = 59	Metformin + Placebo n = 65	OCP + Metformin n = 63
Value	17	17	18

Population analysed: Includes all participants who completed an end of study visit greater than or equal to 16 weeks.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event data was collected for 7 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OCP + Placebo	2 of 79 (2.5%)	71 of 79 (89.9%)	0 of 79
Metformin + Placebo	3 of 81 (3.7%)	76 of 81 (93.8%)	0 of 81
OCP + Metformin	3 of 80 (3.8%)	78 of 80 (97.5%)	0 of 80

Limitations and caveats (from the sponsor): Two outcomes, Changes in HDL-C function assessed by measuring reverse cholesterol efflux capacity using validated ex vivo system and serum adipokines which are to be measured are adiponectin and leptin. We are currently looking for a vendor to run these assays.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41359669Dokras A, Coutifaris C, Remaley AT, Mehta NN, Playford MP, Kunselman AR, Stetter CC, Dodson WC, Legro RS. Impact of combined hormonal contraceptives and metformin on metabolic syndrome in women with hyperandrogenic polycystic ovary syndrome and obesity: The COMET-PCOS randomized clinical trial. PLoS Med. 2025 Dec 8;22(12):e1004662. doi: 10.1371/journal.pmed.1004662. eCollection 2025 Dec.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anuja Dokras, MD principal investigator

University of Pennsylvania

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OCP + Metformin in people with PCOS, run by Anuja Dokras at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Metabolic Syndrome After 6 Months of Treatment Metformin or OCP+Metformin for 6 Months. (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03229057, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.